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Challenges for Cell-Based Medicinal Products From a Pharmaceutical Product Perspective
- Source :
- Journal of Pharmaceutical Sciences. 110:1900-1908
- Publication Year :
- 2021
- Publisher :
- Elsevier BV, 2021.
-
Abstract
- Advanced therapy medicinal products (ATMPs), such as somatic cell-therapy medicinal products or tissue-engineered products for human use, offer new and potentially curative opportunities to treat yet untreatable diseases or disorders. For cell-therapy medicinal products (CBMPs), multiple stability and quality challenges exist and relate to the cellular composition and unstable nature of these parenteral preparations. It is the aim of this review to discuss open questions and problems associated with the development, manufacturing and testing of CBMPs from a pharmaceutical drug product perspective. This includes safety, storage and handling, particulates, the choice of container closure systems and integrity. Analytical methods commonly used to evaluate the quality of the final CBMP to ensure patient's safety will be discussed. Particulate contamination in final products deserve special attention since CBMPs cannot be sterile filtered. Visible and sub-visible particles may represent environmental contaminations or may form during storage. They may be introduced from processing materials such as single use product contact materials, ancillary materials, or any components such as primary packaging used for the final product. Currently available analytical methods for detecting particulates may not be easily applicable to CBMPs due to their inherent particulate nature and appearance.
- Subjects :
- Pharmaceutical drug
Single use
Cellular composition
Computer science
medicine.medical_treatment
media_common.quotation_subject
Final product
Pharmaceutical Science
02 engineering and technology
021001 nanoscience & nanotechnology
030226 pharmacology & pharmacy
Product (business)
03 medical and health sciences
0302 clinical medicine
Pharmaceutical Preparations
Risk analysis (engineering)
medicine
Humans
Quality (business)
Drug Contamination
0210 nano-technology
Drug Packaging
Cell based
Particulate contamination
media_common
Subjects
Details
- ISSN :
- 00223549
- Volume :
- 110
- Database :
- OpenAIRE
- Journal :
- Journal of Pharmaceutical Sciences
- Accession number :
- edsair.doi.dedup.....7323a4531500eebea5e48fd792bc693a
- Full Text :
- https://doi.org/10.1016/j.xphs.2020.11.040